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You’ve probably noticed there’s been a lot of soccer going on recently. We don’t purport to be experts on the “beautiful game,” but every four years we find ourselves riveted by a sport we don’t always watch and sometimes don’t understand. The expanded field of 48 teams generated lots of unexpected excitement, and we thoroughly enjoyed Cape Verde’s Cinderella run into the elimination round, the United States winning their group, the underdog performances from New Zealand, Qatar and Australia, and of course the good-natured Viking antics from the Norwegian team and fans.  

Unlike the world cup games that left us riveted, today’s decision is a bit of a mixed bag and leaves us feeling a little blah (maybe the finals on Sunday between Spain and Argentina will provide one last blast of excitement before we put our weeks-long soccer watching binge on the shelf until 2030). Despite thinking that we’ve seen the last of them, we continue to see cases involving pedicle screws. A few months ago we wrote about a Buckman preemption decision dismissing claims involving pedicle screws.  And today’s decision offers a new take—a lawsuit against the manufacturer of a surgical robot that assists surgeons in placing pedicle screws. Nalder v. Walsh, 2026 WL 1984254 (S.D. Miss. July 9, 2026).

The plaintiff underwent lumbar fusion surgery in which the surgeon utilized a surgical robot to place pedicle screws into the plaintiff’s back. After the surgery, the doctor told the plaintiff that the “robotic arm had malfunctioned and that the L5 right pedicle screw was drilled in the wrong location.” Id. at *1. On a return visit, the plaintiff asked the surgeon how the robot malfunctioned. The doctor told him that the robot “reprogrammed” itself onto an incorrect vertebra, and that caused the surgeon to misplace the screw. The surgeon then had to replace the screw in the correct location during the surgery. The plaintiff claimed to experience neurological defects in his right foot because of the screw misplacement. He filed a malpractice action against his surgeon and included claims against the robot manufacturer for strict liability and breach of warranty. The manufacturer moved to dismiss.

Defendant’s first argument was that the complaint relied on common law strict liability claims that are no longer recognized in Mississippi—they are controlled instead by the Mississippi Products Liability Act (“MPLA”). Despite the complaint’s assertion of common law claims that no longer exist in Mississippi, the court found that the allegations tracked the statute. With that and the acknowledgement by plaintiff in his opposition to the motion to dismiss that his claims were controlled by the MPLA, the court held that the allegations were sufficient to avoid wholesale dismissal. Id. at *2.

Moving on from the threshold question about the MPLA, the court then discussed the facts alleged in the complaint. There were two: (1) the allegations that the surgeon observed the robot’s malfunction and the surgeon blaming the robot for the screw misplacement; and (2) the FDA sent the manufacturer a warning letter six months before the surgery stating that the manufacturer failed to report certain reportable events and identifying five unreported events that suggested the robot device “malfunctioned (i.e, misplaced screws) while in use.” Id. at *4.

The court next looked to whether those allegations were sufficient to state design and manufacturing defect claims. At the outset, the court noted that the complaint did not identify “how the product deviated” from the manufacturer’s design or specifications, and that the complaint did not even “mention” an alternative feasible design—both requirements under the MPLA.  Id. at *4. Absent those, and given the basic requirements of Twombly/Iqbal, we read the decision with the expectation that dismissal would be up next. But in an unexpected curve worse than a Messi corner kick, the court referenced the Seven Circuit Bausch decision—which we’ve previously bashed for its misapplication of Twombly/Iqbal—resulting in plaintiff escaping dismissal in a manner more miraculous than Argentina’s dramatic comebacks against Egypt and England. The court cited to other federal court decisions dismissing claims under the MPLA, including Deese v. Immunex Corp., 2012 WL 463722 (S.D. Miss. Feb 13, 2012) (which we blogged about here), but the court held that the bare-bone factual allegations regarding the surgeon’s statement and the FDA letter were enough to save the claims from dismissal.   

Turning next to failure to warn, the defense argued that the complaint did not allege any facts supporting the failure to warn claim and that it did not plead elements of the learned intermediary rule. The court agreed. The complaint did not identify the warnings the defendant included, did not allege that the surgeon would not have used the device if a different warning had been given, and it did not identify what warning the plaintiff claimed should have been given. Absent those details, the court held that the failure to warn claim was not “factually plausible” and dismissed the claim. Id. at *6.

The court also dismissed plaintiff’s breach of warranty claims. It dismissed the implied warranty claim because plaintiff did not oppose dismissal. For the express warranty claim, the complaint did not meet the requirements under the MPLA that a plaintiff must allege “specific statements or representations” by the defendant. Id. Instead, plaintiff made only conclusory allegations that “failed to identify the express warranties or representations that were allegedly breached.” Id. Given that, the court dismissed the express warranty claim.

It is worth noting that the reference to the FDA letter—which is almost always raised by plaintiffs in an effort to support a warning claim—was used to support the design and manufacturing defect claims.  We think there’s a good argument that a failure to report claim doesn’t exist at all in Mississippi (as we blogged about in our 50 state survey), and that raises the question how the failure to report allegation can ultimately support a design or manufacturing defect claim.  That at least suggests the plaintiff may have a tough time getting past summary judgement. In the meantime we’ll hope to hear more inspiring goal calls by Andrés Cantor this weekend.

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We’ve re-read Monsanto Co. v. Durnell, No. 24-1068, 609 U.S. ___, 2026 LX 336645, 2026 WL 1825691 (June 25, 2026) (“Durnell”), a few times over the past few weeks.  As Bexis noted in his quick-out-of-the gate (and great) analysis, there is a lot in there to use in our medical device preemption cases. 

The point is, just because Durnell involved Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) preemption, please don’t just skim it and move on.

The primary reason why it deserves a spot in your regular preemption authorities rotation is because it extensively and directly relied on Riegel, and it had a lot of good things to say about the meaning of Riegel that will run counter to many arguments you see from the other side of the “v”. 

As the Supreme Court said, Riegel was instructive to its analysis in Durnell, a FIFRA preemption case, because “[i]n Riegel, the Court addressed the preemption clause in the Medical Device Amendments of 1976, which is nearly identical to FIFRA’s preemption clause.”  Durnell, 2026 U.S. LEXIS 2721 at *20 (emphasis added).  In addition:  Both the FDA (for medical devices and OTC drugs) and the EPA (for pesticides) analyze the safety of their regulated products before they can grant approval; both must ensure product labels are “neither false nor misleading”; and after approval, “the manufacturer is required to use that label and is prohibited from making any changes to the device or label” without additional federal approval.  Id.

For our purposes, just as the similarities between the express preemption clauses in the Medical Device Amendments and FIFRA made Riegel “dispositive” of the FIFRA preemption issue in Durnell, the similarities between the two should also make the holding in Durnell dispositive of Durnell-type arguments in your Medical Device Amendment express preemption matters.  See id. at *21 (Supreme Court recognizing that its Durnell “affects more that FIFRA” and applies to cases involving similar preemption provisions, like 21 U.S.C. 360k(a)).

Again: Don’t let good Supreme Court precedent go to waste!

A Durnell Recap

In Durnell, the plaintiff contended that even though the EPA had approved a pesticide’s label without a cancer warning, the manufacturer should have given a cancer warning, and was liable under state tort law for not doing so.  Id. at *6.

The Supreme Court readily found that claim preempted, because that “state tort claim would require [the manufacturer] to add a cancer warning to [the pesticide’s] label even though federal law require[d] [the manufacturer] to use the EPA-approved label without a cancer warning.”  Id. at *6-*7, *14-*15.  Thus, the state law requirement was “in addition to” and “different from” the manufacturer’s federal-law labeling obligations, and preempted.  Id. at *18.

The Supreme Court also shot down three arguments raised by the Durnell plaintiff in trying to avoid preemption.

First, the Durnell plaintiff argued that preemption did not apply because state and federal law were consistent—basically, that Plaintiff’s state law failure-to-warn claim and a “misbranding” provision in FIFRA both require “adequate warnings” that are not “false or misleading.”  Id. at *15, *22. 

That argument failed because it “operate[d] at far too high a level of generality.”   

Looking at only FIFRA’s general standard for misbranding rather than the specific requirements imposed under federal law would nullify FIFRA’s preemption clause and the uniformity that Congress sought for safety warnings on pesticide labels.

Id. at *22.

Although the majority did not explicitly discuss whether or how to state a parallel claim that survives preemption (and the dissent said Riegel never addressed this issue at all, id. at n.9 (Jackson, J. dissenting)), this “misbranding is too general” point is interesting.  It suggests that there must be a good amount of equivalence between the duty under federal law and the duty under state law.  See, e.g., Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (genuinely equivalent); Otis-Wisher v. Medtronic, Inc., 616 F. App’x 433, 434 (2d Cir. 2015) (identical). 

In any event—and this is key—regardless of what warnings the Durnell plaintiff believed should have been given over time, different or additional warnings flew in the face of the specific labeling requirements that the EPA actually had imposed in reviewing and approving specific label language.  Id. at *22.

Second, the Durnell plaintiff suggested that “the EPA-approved and EPA-required label” had “become misbranded over time due to new evidence.”  In essence, they argued that post-approval events had overtaken the EPA’s initial label approval, with new information rendering that label inadequate over time.  Id. at *25-28.  That argument also failed. 

Allowing a post-approval failure-to-warn claim as plaintiff suggested “would negate FIFRA’s express preemption clause, expose manufacturers to potentially massive tort liability for doing what EPA required them to do, and eviscerate the ‘uniformity’ of EPA’s labeling determinations.”  Id. at *28.  

Simply put, the plaintiff’s allegations about new information did not deprive the EPA’s original warning label determinations “of their preemptive force.”  Id. at *29.

Durnell also recognized that such arguments also “contravene” the Supreme Court’s Riegel decision. 

Similar to the EPA’s powers under FIFRA, the FDA is authorized to “withdraw premarket approval for a medical device based on ‘newly reported data or existing information’” and is required to do so if it newly determines the device is unsafe in ineffective.  Id. at *28-29 (quoting Riegel, 552 U.S. at 319).  Despite that federal power to reassess new data and to change its approval decision, the Supreme Court in Riegel still concluded that the in-effect premarket approval imposed federal requirements that preempted state tort suits.  Id. at *29 (citing Riegel, 552 U.S. at 322-23). 

A third, and related, argument was one of policy.  The Durnell plaintiff suggested that the regulatory response would inevitably lag the development of post-approval safety information and thus federal regulation and preemption should step aside and allow that gap to be addressed through plaintiff-driven state tort lawsuits.  Id. at *30. 

The Supreme Court was not swayed.  Not only did its textual analysis of “in addition to” and “different from” express preemption provisions preclude such claims [id. at *18], imposing liability also was unnecessary given regulatory authority.  Similar to what is required of medical device manufacturers, FIFRA requires manufacturers to “apprise EPA of new information ‘regarding unreasonable adverse effects’ of their pesticides”; it allows the EPA to require more information, conduct new scientific analyses, and review third party petitions to modify or cancel a pesticide’s approval”; and it has other mechanisms for outsiders to bring new safety information to the regulator’s attention as well.  Id. at *30-31. 

In other words, the “comprehensive regulatory regime” provides EPA with “a variety of tools to learn of and address new safety information” but in an event, “as a matter of law, state tort law may not impose labeling requirements ‘in addition to’ or ‘different from’ federal requirements imposed under FIFRA.”  Id. at *31.

Using Durnell In Medical Device Preemption Cases

The Supreme Court itself said that Riegel controlled Durnell, and that Durnell would affect more than FIFRA cases, so there is no mystery about whether Durnell matters to the issues in our sandbox.  It does; the Court itself says so.

But more than that, doesn’t Durnell actually wipe out a lot of the parallel-claim nonsense in the medical device sphere?

Think about Bausch v. Stryker Corp., 630 F.3d 546, 554-55 (7th Cir. 2010), in which the Seventh Circuit rejected the defense arguments that Quality System Regulations (QSRs) and CGMPs are “too general to allow juries to enforce them.” But Durnell just said that “misbranding” operated at “far too high a level of generality,” and we would argue that Durnell‘s conclusion carries through to QSRs and CGMPs as well.

Think also about Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013).  Wasn’t that a Durnell-style post-sale duty to warn claim?

In particular, the Stengel plaintiff’s contention, as proposed in an amended complaint, was that the device manufacturer had a federal law “continuing duty to monitor the product after pre-market approval” and a failure to comply with that federal duty breached the “duty to use reasonable care” under Arizona negligence law.  Id. at 1232.  Sorry, but that is a lot of “too high a level of generality” on both the federal requirement side and the state requirement side.

Then there is Stengel’s stated rationale for finding plaintiff’s claim not preempted: “Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers’ unreasonable behavior.”  Id. at 1233. 

Durnell shut that down, recognizing that the regulatory authority afforded the EPA under FIFRA was more than well-equipped to address safety concerns—and if anything, the FDA’s regulatory powers are even greater where PMA medical devices are concerned.   

Of course, the Stengel majority also stepped in to re-work the plaintiff’s claim by purporting to identify a more “precise parallel”—namely the federal requirement to report adverse events to the FDA and a state-law duty to warn.  See id. at 1233.

Judge Watford, in his concurrence, recognized that this gloss meant the plaintiff would “ultimately have to prove that” the new and different information—not included in the federally-required warning label—would have had to reach Mr. Stengel’s doctors, and resulted in a different medical treatment decision that would have prevent his injuries.

Setting apart the other reasons why Stengel is nonsense (see, e.g., here and here), doesn’t this run squarely into the most fundamental point in Durnell?  Durnell looked past all the arguments about new and different information developed post-approval, and recognized this one fundamental truth: A different warning is a different warning is a different warning. 

If the federal regulator didn’t require that warning to be given, then state law cannot require otherwise, full stop. 

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This makes two weeks in a row with vaccine cases. Last week we discussed yet another Constitutional challenge against mandatory vaccination. This week we look at Nguyen v. Sec’y of Health and Human Services, 2026 U.S. Claims LEXIS 1650 (U.S. Ct. Fed. Claims June 22, 2026), a federal circuit Vaccine Act compensation case.  Such cases are infrequently interesting, but this one contains one of the most thorough take-downs of case reports as poor quality scientific evidence that you will likely ever see.  

The claim in Nguyen, which was rejected, was that a hepatitis B vaccine caused the plaintiff to suffer from a neurological condition, Guillain-Barré syndrome (GBS). Because GBS was not listed on the relevant Vaccine Table, this was a non-table injury case (duh), and thus the plaintiff had to satisfy “traditional causation standards” (not so duh). More specifically, the plaintiff needed to present preponderant evidence of (1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect; and (3) a temporal relationship between vaccination and injury.  The court accepted that the plaintiff met the requirement of temporal relationship (the GBS hit the plaintiff between two and five weeks after the vaccination).  So that’s one out of the three requirements being met.  But that’s it. And, riffing off the old Meatloaf song, one of three is bad. 

The court did not see a logical cause and effect scenario, so that was bad news for the plaintiff — bad enough to end the case.  But the court devoted most of its analysis to the medical causation theory, and there the plaintiff had serious problems.  

First, the plaintiff proffered a neurological expert with fine qualifications in the field of neurology, but the real issue here was immunology. The mismatch between expertise and the issue at hand was viewed by the court as a “detriment” to the plaintiff’s case.  The defense expert, too, was a neurologist, not immunologist. That, too, is a detriment, but it is the plaintiff, not the defendant, who “bears the burden of presenting a persuasive case.”

Then the Nguyen court carefully analyzed both the case law and epidemiology on vaccination causation of GBS. The plaintiff’s proposed biological mechanism was “molecular mimicry,” which had support that could be characterized as frail at best.  The epi studies either involved a different vaccine or reliance on an unreliable database (described in another case as a “stocked pond”), and discredited experts. At most, the plaintiff could claim a standoff on epidemiology – again, that is not enough to meet the plaintiff’s burden. 

That leaves us with case reports and case series.  This is the part of the case that will most gladden the flinty hearts of defense hacks. A case report equals mere anecdote, and “anecdote” is not the singular of “data.”  Other Federal Circuit cases considering vaccine claims have “endorsed, albeit indirectly, a view that case reports merit little weight.” The Nguyen court does a good job of collecting many cases discounting case reports, both in and out (e.g., the Abilify MDL) of the vaccine program. Then, “in accord with these judicial authorities,” the Nguyen court declined to give the plaintiff’s “case reports much, if any weight.” Even beyond the general principle that case reports are weak, the particular ones cited by the plaintiff were especially off the mark. 

The Nguyen court directly confronted another case that came to a contrary result. The “primary difference” between the cases was the weight of case reports, and the Nguyen court held that the weight was too little to permit the plaintiff to proceed with the vaccine compensation claim. Naturally, we side with the Nguyen case and give a bitter side-eye to the more lenient, permissive, pro-plaintiff case. 

For any case you work on in which the evidentiary value of case reports is an issue, Nguyen is worth review and citation.

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There’s an old joke about a guy who keeps banging his head against the wall. When asked why, he says: Because it feels so good when I stop. That’s roughly how we feel about watching defendants in medical device cases make preemption arguments under the shadow of Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). The head-banging is painful. It never really stops. But somebody has to keep doing it, because the wall eventually has to come down.

The latest occasion for this exercise is Dyer v. Coloplast Corp., 2026 WL 1906706 (M.D. Fla. July 2, 2026) — a pelvic mesh case in which the defendant lost its preemption arguments on summary judgment. We are not happy about it. We are, however, not surprised. And we think the defendant was right to try, and should keep trying, because Lohr is a flawed decision and we’ve said so here for years.

Plaintiff underwent pelvic floor reconstructive surgery during which a surgeon implanted defendant’s mesh — an §510(k)-cleared Class II medical device — to treat stress urinary incontinence. Dyer, 2026 WL 1906706, at *1. Plaintiff developed pelvic, groin, and lower extremity pain, was diagnosed with neuralgias, and underwent two additional surgeries. Id. She sued the manufacturer for negligence, strict liability design defect, and strict liability failure to warn, and also sought punitive damages under Florida law. Id.

The defendant moved for summary judgment on several grounds—most notably that plaintiff’s design defect claims were impliedly preempted because, pursuant to FDA regulations it could not unilaterally change the mesh’s design without going through the §510(k) process. Id. Before deciding the impossibility preemption issue, the court noted the elephant that has been in the room for thirty years — the Supreme Court’s ruling in Lohr that §360k does not expressly preempt state-law design defect claims against §510(k)-cleared devices. Id. at *2. Lohr has been in our crosshairs for a long time, and not just because it goes against defendants. It is a jurisprudential mess. A fragmented plurality opinion whose central reasoning has been chipped away, overruled, or repudiated by nearly every subsequent Supreme Court decision to touch it.

We’ve laid out the case against Lohr in detail several times.  The short version: Lohr‘s anti-preemptive reasoning rested on (a) the presumption against preemption in express preemption cases; (b) deference to an FDA regulation (21 C.F.R. § 808.1(d)) restricting the preemptive scope of §360k(a); and (c) the Court’s gestalt view that Congress could not have intended to bar most tort relief for injured patients. Every one of those foundations has since been kicked out from under it.

So yes, Lohr controls on the express preemption issue for §510(k)-cleared devices. But that is a wall that needs to be brought down. The way to bring it down is to get a well-built record before a court willing to send the issue up, and to keep the issue alive and preserved in every case until the Supreme Court takes it.

In the meantime, the implied preemption argument is valid. It just needs to be paired with a common-law argument that the court in Dyer never addressed. The court rejected defendant’s implied preemption argument finding that the manufacturer “had complete and independent control over the [mesh’s] design before it sought §510(k) clearance for the device,” and therefore “[i]t was not impossible to simultaneously comply with federal and state law.” Id. at *3 (emphasis added, citations omitted).

But generally speaking state product liability law requires a finding that a product is defective when it leaves the defendant’s possession, not at some earlier time. The design defect theory the Dyer court allowed to survive is premised not on what the mesh was when it left defendant’s control post-clearance, but on what it should have looked like before it was ever submitted to the FDA for clearance. In other words — you could have designed it differently before you ever went to the FDA. Therefore, no impossibility. Therefore, no preemption.

But that reasoning has a common-law problem. The product liability claim is not against the defendant’s hypothetical, never-manufactured alternative design from years before FDA submission. It is against the device as actually sold. At the time of sale — indeed, at the time of submission — the device’s design was subject to federal clearance requirements. A state tort judgment holding that the design was defective is a judgment that the defendant should have done something different. What it should have done, according to the plaintiff’s theory, is submit a different design to the FDA. That is the very essence of a “stop selling” or “never start selling” claim that the Supreme Court held preempted in Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). Bartlett‘s logic applies here with full force. If the only way to comply with the state-law duty is not to have marketed the product in its FDA-cleared form, then complying with state law would have required federal regulatory action — the submission of a different §510(k) — that the defendant could not independently accomplish.

None of this analysis was in the opinion, but it should be in the next motion, and the next, and the one after that.

While the preemption ruling is probably our biggest problem with Dyer, it isn’t our only one. The failure to warn ruling illustrates a recurring problem. The IFU warned of pain, neuromuscular symptoms, chronic complications, and the need for revision surgery – the very injuries plaintiff claims. Dyer at *4. But the court let the claim proceed anyway, because plaintiff’s expert said the warning should also have included comparative risk data comparing transobturator slings with retropubic slings. Id. at *5.

This is the classic no-win warning game. No matter how comprehensive the IFU, some expert can always find something more that allegedly should have been said. The information that plaintiff says was missing here — comparative complication rates between sling types — has never been held necessary to an adequate warning by any Florida appellate court. The two cases the court cited are federal district court cases, neither of which is binding. Yet a Florida product liability defendant is now going to trial on a warning claim premised on a duty that Florida’s own courts have never recognized.

This is a textbook Erie problem. Federal courts sitting in diversity are supposed to apply existing state tort law, not expand it to include duties no state appellate court has ever imposed. Telling a physician that a transobturator sling carries a different risk profile than a retropubic sling is not a warning about potential harmful consequences — it is a comparative marketing disclosure. Florida has never required that.

One piece of good news. The court granted summary judgment against punitive damages. Id. at *7-8. Under Florida law, a plaintiff seeking punitive damages must show by clear and convincing evidence that the defendant was personally guilty of intentional misconduct or gross negligence — the latter defined as conduct “so reckless or wanting in care that it constituted a conscious disregard or indifference to the life, safety, or rights of persons exposed to such conduct.” Fla. Stat. § 768.72(2)(b). The court quoted the observation from Tesla, Inc. v. Banner, 411 So. 3d 1, 5 (Fla. 4th DCA 2025), that “[i]t would appear that the Florida Supreme Court has all but eliminated punitive damage awards in products liability cases.” Dyer, at *7. Plaintiff, whose response brief simply recycled her design defect and failure to warn arguments, never came close to meeting that standard. Summary judgment on punitives granted. Id. at *8.

We will take our wins where we can get them.

The defendant in Dyer lost the battles that almost every defendant in a §510(k) medical device case loses. That is the current state of play under Lohr‘s long shadow. But the shadow is not permanent. The jurisprudential ground beneath Lohr has been eroding for years. The express preemption argument, the properly-framed implied preemption argument paired with a state tort law defect-at-sale rule and Bartlett‘s stop-selling logic, and the Erie objection to court-created comparative warning duties — these are all worth pursuing, on the right record, in the right court. Keep banging. The wall will come down.

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Late last year, when we were putting together our massive post that collected and categorized every case that had ever judicially noticed an FDA document, we ran across the intriguing proposition that in deciding Rule 12 pleading-based motions, “allegations in a complaint are not credited where contradicted by judicially noticeable documents.”  We cited several appellate decisions for that principle.  The most recent one, Fuqua v. Santa Fe County Sheriff’s Office, 157 F.4th 1288 (10th Cir. 2025), stated:

The general rule prohibiting courts from considering evidence outside the complaint on a motion to dismiss has an[] exception:  matters of which a court may take judicial notice.  Judicial notice allows the court to accept a matter as proved without requiring the party to offer evidence of it.  And taking judicial notice precludes a party from introducing contrary evidence and, in effect, directs a verdict against him as to the fact noticed.

Id. at 1298 (citations and quotation marks omitted).  Fuqua cited a Supreme Court case for this point, Tellabs, Inc. v. Makor Issues & Rights, Ltd., 551 U.S. 308 (2007).  The Supreme Court held in that case, that in adjudicating Rule 12(b)(6) motions, “courts must consider the complaint in its entirety, as well as other sources courts ordinarily examine” such as “matters of which a court may take judicial notice.”  Id. at 322.

Other cases for this proposition include Sprewell v. Golden State Warriors, 266 F.3d 979 (9th Cir. 2001), affirming that in the 12(b)(6) context, courts “need not . . . accept as true allegations that contradict matters properly subject to judicial notice” or that “are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.”  Id. at 988 (citations omitted).  The Sprewell decision has been particularly influential and has been followed by several other Ninth Circuit decisions.  Readers of this post will notice a disproportionately high percentage of the cases discussed below are from Ninth Circuit district courts.

For additional appellate authority supporting the general proposition that judicial notice trumps contrary pleadings, see Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024) (affirming dismissal when considering“ all matters of proper judicial notice”) (citation and quotation marks omitted); Secured Mail Solutions LLC v. Universal Wilde, Inc., 873 F.3d 905, 913 (Fed. Cir. 2017) (“[i]n ruling on a 12(b)(6) motion, a court need not accept as true allegations that contradict matters properly subject to judicial notice”) (citation and quotation marks omitted); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021) (“this court may take judicial notice of public records, and we are not required to accept as true factual allegations that are contradicted by those records”) (citation omitted); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014) (courts “need not accept allegations that contradict matters properly subject to judicial notice”) (citation and quotation marks omitted); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004) (“Nor must we accept as true the complaint’s factual allegations insofar as they contradict . . . matters subject to judicial notice”) (citation omitted); Gupta v. Wipro Ltd., 749 F. Appx. 94, 97 (3d Cir. 2018) (“Although we generally must accept as true the complaint’s factual allegations, this requirement does not apply when the allegations are contradicted by . . . matters subject to judicial notice.”) (citation and quotation marks omitted).

We decided to look for cases that apply the general proposition that courts need not accept as true allegations refuted by matters subject to judicial notice in the specific context of prescription medical product liability litigation.  One such case is Plumlee v. Pfizer, Inc., 2014 WL 4275519 (N.D. Cal. Aug. 29, 2014), where the court took judicial notice of a drug’s FDA-approved labeling and certain changes to that labeling that also went through proper FDA regulatory channels.  Id. at *4 & n.2.  The court also took judicial notice of the existence of “dozens of exhibits submitted by Defendant” that “directly contradict Plaintiff’s claim.”  Id. at 8.  Those exhibits established that, contrary to the plaintiff’s allegations, she could not, as a “reasonable consumer,” have been “ignorant” of the issue she belatedly sought to litigate after the expiration of the statute of limitations.  Id. at *8.

On appeal, the Ninth Circuit affirmed.

[T]he district court took judicial notice of an extensive record of documents − all publicly available during the relevant limitations periods − which discussed [the efficacy issues raised by plaintiff’s complaint]. The district court did not err in taking judicial notice of these documents.  The judicially noticed documents either identified [the drug] specifically or referred to antidepressants generally. . . . Therefore, the district court properly rejected [plaintiff’s] allegation that no information questioning [the drug’s] efficacy existed within the three- and four-year limitations periods. . . to which a reasonably diligent consumer would have been exposed.

Plumlee v. Pfizer, Inc., 664 F. Appx. 651, 653-54 (9th Cir. 2016).

Chapman v. Abbott Laboratories, 930 F. Supp.2d 1321 (M.D. Fla. 2013), reached a similar result.  In Chapman the plaintiff’s allegations about the drug’s warnings were directly contradicted by its FDA-approved labeling, which was subject to judicial notice.

[Plaintiff’s] claim is squarely contradicted by the . . . judicially-noticed drug label that does contain warnings. . . .  This conflict renders implausible the failure to warn theory as currently pled in [plaintiff’s] strict liability and negligence counts. . . .  [It is] clear that the overarching theme of [plaintiff’s] case is failure to warn, as evidenced by [plaintiff’s] counsel’s summary of the action in his response to the motion to dismiss. . . .   Accordingly, the Court will grant the motion to dismiss insofar as it seeks dismissal of the strict liability and negligence counts.

Id. at 1323-24 (citation omitted).

Another example is De La Paz v. Bayer Healthcare LLC, 159 F. Supp.3d 1085 (N.D. Cal. 2016).  Relying on judicially noticed FDA enforcement materials (Forms 483) the court dismissed the plaintiff’s manufacturing defect claims because they misconstrued the contents of those documents:

[T]o escape implied preemption [plaintiff] must allege that the irregularities documented in the Form 483s resulted in a manufacturing defect that caused her injuries. . . .  [Plaintiff] has failed to allege such a manufacturing defect.

The complaint offers no description of the “non-conforming material” used in manufacturing the device, or how the use of that material caused a defect in the product itself.  In fact, the Form 483 indicated that [defendant’s] contract manufacturer used the “non-conforming material” in a validation protocol, not in the actual manufacture of the product.  Moreover, the report indicated that the manufacturer had erred by failing to adequately document the disposition of that material, not by using the material itself.  [Plaintiff] has provided no basis for concluding that the failure to document the disposition of non-conforming material in a validation protocol caused a manufacturing defect in any . . . device.

Id. at 1094-95 (citations omitted).  See also Id. at 1096, 1098 (additional dismissals of failure to train and express warranty claims due to contradiction with judicially noticed FDA documents).

Likewise, in Trisvan v. Heyman, 305 F. Supp.3d 381 (E.D.N.Y. 2018), the plaintiff alleged – falsely – “that there were no warnings about the relevant side-effects” with the defendant’s drug.  Id. at 399 (emphasis original).  Since the defendant’s judicially noticed warnings (and the Physician’s Desk Reference) belied that allegation, it was ignored and the aspect of the plaintiff’s complaint was dismissed:

In contrast to most other failure to warn cases, the adequacy of the warning in this action turns on its mere existence.  Defendants, however, have offered FDA-approved labels as evidence of warnings provided to physicians contemporaneous with or predating Plaintiff’s use. . . .  At the very least, these FDA labels list [specific warnings omitted].  Accordingly, Plaintiff’s failure to warn claims based on a lack of any warnings are dismissed with prejudice.

Id. at 400 (citations omitted).  Accord Trisvan v. Heyman, 2018 WL 6573434, at *4-5 (E.D.N.Y. Dec. 13, 2018) (second dismissal for “allegations in a complaint that contradict or are inconsistent with judicially-noticed facts”) (footnote omitted).

In Carter v. Amgen, Inc., 2015 WL 13388039 (C.D. Cal. July 16, 2015), aff’d, 682 F. Appx. 620 (9th Cir. 2017), plaintiff repeatedly alleged, in conclusory function, that the relevant use of a drug was “contraindicated.  Id. at 6.  “[J]udicially noticed FDA labels” established that these allegations were untrue, and the claim was dismissed:

[T]he contraindicated allegation is directly contradicted by the FDA-approved labels that the Court has judicially noticed. . . .  The labels each contain a section entitled “Contraindications”. . . .  [discussion of labeled contraindications omitted]  Thus, the Court need not accept as true the allegation that [the drug] was “contraindicated” for [decedent’s] use of the drug because the judicially noticed labels demonstrate that the allegation blatantly false.

Id. (citations and quotation marks omitted).

The same result occurred in Becker v. Cephalon, Inc., 2015 WL 5472311 (S.D.N.Y. Sept. 15, 2015).  Plaintiff’s warning-related allegations were “squarely contradicted” by the drug’s judicially noticed labeling, requiring their dismissal:

While a court must generally accept a plaintiff’s factual allegations as true in evaluating a motion to dismiss, it need not accept as true allegations in a complaint that contradict or are inconsistent with judicially-noticed facts.  Plaintiff’s allegations that [defendant] failed to warn of the risk [at issue] when taking [the drug] . . . are squarely contradicted by the [drug’s] label. . . .  Because all of the alleged side effects described by Plaintiff are specifically indicated as potential side effects in the drug’s package insert, . . . Plaintiff’s strict liability and negligence products liability claims based on a failure to warn theory are foreclosed and must be dismissed.

Id. at *5-6 (citations and quotation marks omitted).

Those decisions are hardly all the examples we found of contradictions with judicially noticed material resulting in Rule 12 dismissal.  Here are a bunch of other cases where FDA materials or other unimpeachable documents concerning FDA regulated products were judicially noticed and resulted in dismissal of claims, despite contrary pleaded allegations.  Govea v. Medtronic, Inc., 2025 WL 3467214, at *13 (C.D. Cal. Nov. 26, 2025) (judicially noticed FDA device approval establishes its intended uses; plaintiff’s claim of off-label promotion is dismissed because it concerned a labeled use); Brock v. City of Bellingham, 2025 WL 254725, at *5 (W.D. Wash. Jan. 21, 2025) (judicially noticing FDA COVID vaccine emergency use approvals; “[g]iven the judicially noticeable facts . . ., the Court concludes that the . . . vaccine available to Plaintiffs was not an ‘investigational drug’ at any time relevant to Plaintiffs’ claims”); Argueta v. Walgreens Co., 760 F. Supp.3d 1028, 1038 (E.D. Cal. 2024) (complaint dismissed where court took judicial notice that the defendant’s product “is indeed a drug approved for the treatment” of the relevant condition); Curtis v. PeaceHealth, 2024 WL 248719, at *2 (W.D. Wash. Jan. 23, 2024) (same as prior Curtis holding), aff’d, 154 F.4th 678 (9th Cir. 2025); Curtis v. Inslee, 709 F. Supp.3d 1257, 1265 (W.D. Wash. 2023) (The COVID vaccine’s status “is accurately and readily determined from the FDA’s approval and CDC’s explanation,” which “are sources whose accuracy cannot be reasonably questioned”), aff’d, 154 F.4th 678 (9th Cir. 2025); Leake v. Raytheon Technologies Corp., 2023 WL 2242857, at *1 n.2 (D. Ariz. Feb. 27, 2023) (judicially noticed FDA information established that allegation of a product recall was “demonstrably false”), aff’d, 2024 WL 1854287 (9th Cir. April 29, 2024); Morris v. Sun Pharma Global, Inc., 2021 WL 3913191, at *3 (C.D. Cal. May 13, 2021) (allegation that defendant was a drug “manufacturer” contradicted by judicially noticed FDA document listing defendant as a “distributor”; “[a]ll of Plaintiff’s allegations based on negligence relate to the manufacturing, not the distribution, of [the drug]”, so “Plaintiff fails to state a negligence claim”); Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *4 (E.D.N.Y. Feb. 16, 2021) (judicial notice taken of drug labeling; “plaintiff’s conclusory allegations coupled with plaintiff’s allegations of suffering from the very side effects of which defendant warns, require dismissal of plaintiff’s claim”); Dye v. Covidien LP, 470 F. Supp.3d 1329, 1341 (S.D. Fla. 2020) (judicial notice taken of FDA-approved device instructions for use; “[c]learly, the IFU contradicts all of Plaintiff’s allegations”); Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1163 & n.5 (E.D. Cal. 2019) (warning claims dismissed as inconsistent with judicially noticed drug label); Lifeway Foods, Inc. v. Millenium Products, Inc., 2016 WL 7336721, at *2 (C.D. Cal. Dec. 14, 2016) (non-prescription medical product case; judicially noticed FDA letters; “this Court . . . will not blindly accept allegations which are directly contradicted by evidence subject to judicial notice”); Porter v. Wetzel, 2012 WL 4442792, at *5 (Mag. W.D. Pa. Aug. 24, 2012) (judicial notice of FDA approval established that, contrary to the complaint, plaintiff received appropriate medical care), adopted, 2012 WL 4378116 (W.D. Pa. Sept. 25, 2012); In re Bayer Corp. Combination Aspirin Products Marketing & Sales Practices Litigation, 701 F. Supp.2d 356, 367-68 (E.D.N.Y. 2010) (allegations contrary to judicially noticed FDA documents disregarded; “[a]lthough . . . a motion to dismiss . . . tak[es] all the allegations as true . . ., the court is not required to reason in a vacuum”).

As our earlier post demonstrated, many types of FDA materials have properly been the subject of judicial notice.  To the extent that a complaint makes factually false allegations that defense counsel can refute by judicially noticeable FDA documents, these allegations can be disregarded for purposes of otherwise pleadings-based motions under Rule 12.  Successfully doing so can be of great value to our clients, which are thereby spared the expense and bother of discovery that waiting for summary judgment would otherwise require.

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Today’s guest post is by Kevin Hara, of Reed Smith, who is pinch-hitting for Steve Boranian. His post today discusses the Texas Supreme Court’s procedural reversal of a lower court’s refusal to hear an interlocutory appeal concerning application of a Texas distributor immunity statute arising in the context of an FDA-regulated drug. The distributor’s motion to dismiss had been denied by the lower court’s creation of a “product liability” limitation on the statute that was contrary to the statute’s express terms. As always, our guest posters should receive all the credit (and any blame) for their writings.

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It is an honor to pinch-hit for a great friend and mentor, one of the regular contributors to this esteemed blog who is enjoying a much-deserved respite.  As readers of this blog are aware, Plaintiffs and their attorneys are relentlessly seek to circumvent limitations on defendants’ liability, whether through creative pleading, trying to categorize the learned intermediary rule as an affirmative defense (it is not), pleading around defenses like the statute of limitations and preemption, blatant forum shopping—a plaintiffs’ playbook favorite—or in today’s case, seeking to evade the plain language of a Texas statute that limits the liability of non-manufacturing sellers. See Tex. Civ. Prac. & Rem. Code § 82.003. (“Section 82.003”).

The Texas Supreme Court recently issued an important procedural decision granting interlocutory review for a “substantial ground for difference of opinion” as to the interpretation of Section 82.003 that will potentially eliminate liability for the distributor in this featured action and other non-manufacturing sellers in the future.  That is good news, because Texas has often been problematic for product liability defendants, as the jurisdiction that invented the heeding presumption (which Texas thankfully no longer applies to prescription medical products), and a very late (if relatively enthusiastic) adopter of the learned intermediary rule.

In McKesson Medical-Surgical Inc. v. Cleveland, No. 26-0005, 2026 Tex. LEXIS 654, at *1-2 (Tex. June 26, 2026), the plaintiff died after visiting a medical spa, allegedly as a result of an infusion containing Total Parenteral Nutrition (“TPN”) electrolytes, an FDA-regulated drug that is administered intravenously to persons with impaired digestive systems due to medical conditions that inhibit their ability to process food and absorb nutrients.

The decedent’s relatives filed suit in Texas state court against the spa and the distributor of the TPN electrolytes; the latter moved to dismiss under Section 82.003.  This statute provides that “[a] seller that did not manufacture a product is not liable for harm caused to the claimant by that product unless the claimant proves” one of seven possible exceptions, including the types of involvement—inter alia, product design, warnings, alterations, express warranties, or knowledge of pre-existing product defects—that are not typical of distributors that act as conduits for supplying pharmaceuticals and medical devices in their original form.  See Section 82.003(a)(1)-(7).  Many states have similar “sealed package” statutes designed to insulate non-manufacturing sellers from liability.  This is sound policy because distributors (often named to defeat diversity) generally have no input or control over the design, manufacture, or warnings pertaining to such products.  Nor would they have knowledge of any alleged defects.  Therefore, statutes analogous to Section 82.003(a) are an important part of the arsenal in defending product liability actions as Bexis detailed here.

The plain language of the statute precludes liability against the distributor of the TPN electrolytes unless the plaintiffs establish one of the enumerated exceptions, and one would think that would be the end of the story.  If only things were that easy.  Unfortunately, that unambiguous language was not enough—at least for now.  Plaintiffs argued that the statute “applie[d] only to product liability actions,” not to their claim, simply because they chose not to allege that the “TPN electrolytes were defective.”  Rather, they contended that the distributor negligently created “an online portal” allowing an unlicensed purchaser to order TPN electrolytes for shipment to the spa.  Cleveland, 2026 Tex. LEXIS 654, at *2-3.  Notably, the statute contains no product liability limitation, nor is the “negligence” argument one of the seven exceptions to Section 82.003(a).

However, this atextual limitation was enough for the trial court to deny the distributor’s motion to dismiss, agreeing that Section 82.003(a) “[did] not apply to sellers, . . ., in cases that are not ‘product liability actions,’” while citing no appellate authority supporting its conclusion.  The trial court acknowledged that the only on-point case, Lopez v. Huron, 490 S.W.3d 517 (Tex. App. 2016), was “potentially doubtful” because the statutory language did not limit its application to product liability actions. Cleveland, 2026 Tex. LEXIS 654, at *3.  That doubt led the trial court to grant the distributor’s request to appeal, framing the legal question: “whether [Section] 82.003(a) . . . applies to sellers in cases that are not product liability actions or whether it applies only to sellers in ‘products liability actions’ or cases where damages are allegedly caused by defective products.”  Id. (quotations omitted.)

That led to more obstruction.  The intermediate appellate court denied the petition, ruling that the distributor failed to show “‘a substantial ground for difference of opinion’ regarding the controlling legal question.”  Id. at *4.  That court also concluded that the absence of authority contrary to Lopez weighed against allowing the appeal.  Id.  Fortunately, the Texas Supreme Court disagreed—finding that while the existence of conflicting authority “strongly suggests a substantial ground for difference of opinion,” . . . “an actual conflict” is unnecessary “when the statute is subject to competing reasonable interpretations.”  Id.  The Texas high court cited the “express acknowledgment” in Lopez that its conclusion was at odds with Section 82.003(a)’s text as enough to establish “that reasonable jurists could disagree with Lopez regarding Section 82.003(a)’s scope.”  Id.  Conversely, the trial court acknowledged Section 82.003(a) has more than one plausible interpretation and that the Texas Supreme Court had yet to render a definitive decision on the issue.  Accordingly, there was “a substantial ground” for differing opinions under Tex. Civ. Prac. & Rem. Code § 51.014(d)(1) (providing the usual “controlling question” and “substantial grounds” test for interlocutory appeals by permission).  The Texas Supreme Court specifically stated that the “substantial ground for difference of opinion” standard is broad, rather than restrictive, designed to permit appeals of “genuinely disputed legal questions in varied contexts.”  Cleveland, 2026 Tex. LEXIS 654, at *5 n.1.

Further, while not deciding whether principles of statutory construction—discussed in the appellate court opinion—merited following Lopez, the Texas Supreme Court highlighted that the “potential clash with Section 82.003(a)’s plain text substantiates that an interlocutory appeal is appropriate.”  Id. at *5.  The court rejected the court of appeal’s reliance on “passing comments” in another case that stated only “that non-manufacturing sellers are not liable for product defects,” finding that action “indisputably involved alleged product defects.”  Id., citing Amazon.com, Inc. v. McMillan, 625 S.W.3d 101, 109 (Tex. 2021).

Against that backdrop, the Texas Supreme Court ruled that the appellate court erred in concluding that the distributor failed to satisfy the criteria for Section 51.014(d)(1) and never addressed the statute’s second requirement—whether “an immediate appeal . . . may materially advance the ultimate termination of the litigation.” Id., citing Section 51.014(d)(2).  In contrast, the trial court ruled an immediate appeal would “resolve a dispositive legal question prior to trial . . . because a ruling in [the distributor’s] favor” on Section 82.003(a) would “eliminate all potential claims.”  Id. at *5-6.  The court favorably cited prior appeals that obviated discovery burdens, “eliminate[d] the need for further litigation,” or would be dispositive of at least some of the claims against the defendants.  Id. at *6.

Plaintiffs argued an immediate appeal would “neither streamline the litigation nor dispose of all claims,” and that resolution of the applicability of the enumerated exceptions in Section 82.003(a) would not result in the distributor’s dismissal.  Id.  That was a straw man, as plaintiffs never alleged they met Section 82.003(a)’s exceptions, and therefore, if the statute applied, it would dispose of all the claims against the distributor—sufficient to satisfy Section 51.014(d)(2).  Id. at *6-7.  The Supreme Court emphasized that this was “precisely the kind of case in which an immediate appeal would allow for the efficient correction of error instead of risking the waste of judicial and party resources.”  Id. at *7 (emphasis added).

Thus, the “court of appeals erred in concluding that there was no substantial ground for difference of opinion” and should have granted the request for an appeal because “(1) the statutory construction question has not been decided by this Court and has more than one plausible answer and (2) resolution of the question may materially advance the litigation’s termination.”  Id.  Thankfully, the court granted the petition for review and ordered the appellate court to accept the appeal.  Id.  The Texas Supreme Court’s decision is one step in the right direction and gives the distributor and other sellers hope for the future.  This case still bears watching for a Texas two-step: a successful appeal and dismissal of the distributor under Section 82.003(a).

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This post comes from the non-RS and non-Dechert side of the Blog.

The great post-modern existentialist philosopher John Madden once said, “If you have two quarterbacks, you actually have no quarterback.”  This was not the result of a fanciful math equation where you (impermissibly) divide by zero.  In American football, except on rare trick plays, only one quarterback will be on the field at the same time (even though up to six players on offense are eligible to throw the ball forward in a given play).  Splitting the practice and game snaps nearly evenly between two different quarterbacks tends to be a bad idea.  The saying does not really translate to the other football, except perhaps if you swap in “goalkeeper” for “quarterback.”  What about product liability claims?  Can two separate products cause the plaintiff’s claimed injury?  In most jurisdictions, depending on timing, yes.  What about 179 separate products to which the plaintiff was allegedly exposed on a regular basis for more than a decade leading up to the diagnosis of his claimed injuries?  No way.  We doubt that any complaint with that basic fact pattern could even make sufficient factual assertions to get past a motion to dismiss in federal court.

The plaintiff in Martinez v. Kraft Heinz Co., No. 2:25-cv-00377, 2026 WL 1878602 (E.D. Pa. June 30, 2026), sure could not do it in two tries and was not given a third chance.  The Martinez plaintiff claimed to have developed type 2 diabetes and steatohepatitis (fatty liver) by the time he was sixteen.  He blamed this on his collective use of 179 different food and beverage products that he had been voluntarily consuming on a regular basis since he was 3 years old.  His lawyers lumped these together as “Ultra Processed Foods” and threw together a very long and obviously templated complaint to detail the purported risks of these products, their ingredients, and aspects of their manufacturing.  Presumably, the core of these allegations could be used to try to support a general link between a bunch of different products and a range of diseases/conditions.  Perhaps, the individual products and their manufacturers were selected by the lawyers to be addressed in any complaint rather than coming from the actual list of what foods this plaintiff had been consuming regularly over that thirteen year period.  In any event, plaintiff’s first complaint failed to meet TwIqbal standards for causation, which was required for each of his asserted claims.  The “shotgun approach” did not “identify any specific products consumed by Martinez, when or how they were consumed, or how that consumption relates to Martinez’s diagnoses,” leaving it uncertain “who is responsible for what.”  Id. at *3.  Defendants had wisely removed this case from the Philadelphia Court of Common Pleas, where the pleading standards would surely have been more lenient. 

The amended complaint, presumably intended to correct the failures the court had previously identified, is what we are discussing here.  Perhaps because he knew he could not offer the required defendant- and product-specific allegations he needed, plaintiff also tried to get the court to bite on inapplicable theories of liability.  As it was, plaintiff’s second complaint attempted more misdirection and fearmongering rather than offering factual assertions that might have established legal causation.  “[A]llegations of increased risk, biological plausibility, and association do not show that any particular product—and particular Defendant’s product—actually caused Martinez’s diagnoses.”  Id. at *6.  None of the non-Pennsylvania law that plaintiff cited supported that his collective causation assertions could suffice for specific causation.  For us, there was a good source of the applicable law not discussed in Martinez that further supports the ruling.  Pennsylvania has Suggested Standard Jury Instructions, including one on “factual cause” that would have applied to plaintiff’s claims had they proceeded to trial.  The unaltered text of the current SSJI (Civ) § 13.20 is as follows:

In order for [name of plaintiff] to recover in this case, [name of defendant]’ s [negligent] [grossly negligent] [reckless] conduct must have been a factual cause in bringing about harm. Conduct is a factual cause of harm when the harm would not have occurred absent the conduct. To be a factual cause, the conduct must have been an actual, real factor in causing the harm, even if the result is unusual or unexpected. A factual cause cannot be an imaginary or fanciful factor having no connection or only an insignificant connection with the harm.

To be a factual cause, [name of defendant]’s conduct need not be the only factual cause. The fact that some other causes concur with [name of defendant]’ s negligence in producing an injury does not relieve [name of defendant] from liability as long as [his] [her] [their] own negligence is a factual cause of the injury.

The Subcommittee’s notes also cite a number of Pennsylvania cases explaining the specific causation standards, including in cases with multiple defendants, although none of them were cited in Martinez.  Taking even what seems to be plaintiff’s allegedly most-often consumed product, a particular brand of cheese slice, its contribution to plaintiff’s alleged injuries would undoubtedly be an “imaginary or fanciful factor having no connection or only an insignificant connection with” his alleged injuries when lumped together with 178 other allegedly harmful food items that plaintiff also regularly consumed.  Even if the complaint had been pared down to omit mention of most of the other allegedly harmful food items that plaintiff regularly consumed, it is hard to imagine a plausible allegation that the consumption of these cheese slices was “an actual, real factor” in him developing diabetes in light of his overall diet, to say nothing of his genetics, activity level, and other risk factors.  Without much more, it is even more implausible that the same 179 products were factual causes of both of plaintiff’s diagnoses.

Of course, plaintiff and his lawyers made the decision to target 179 different products sold by eleven different companies, which made it much harder to offer factual allegations sufficient to establish plausible specific causation under TwIqbal.  Were we deciding the adequacy of plaintiff’s complaints, we might have said plaintiff bit off more than he could chew or had eyes bigger than his stomach, but the Martinez court was overtly sympathetic to plaintiff.  It noted that the causation pleading requirement “creates a unique challenge for plaintiffs, like Martinez, who consume a large number of products over a lengthy period of time.”  Id. at *4.  Frankly, we draw the opposite conclusion from the court’s observation that “Martinez casts a wide net in seeking to hold numerous food producers liable for illnesses resulting from his consumption of nearly two hundred different products over the court of multiple years.”  Id.  It is not a failing of the law that plaintiff did not have a plausible causation story to assert.  It is not unfair that a defendant gets to insist that a liability be based on proof that its conduct caused plaintiff’s injury.  Plaintiff’s burden does not diminish because he sues ten other defendants and claims that 150 or so of their products also caused his injuries.  The court’s sympathy, though, led it to consider and reject plaintiff’s attempts to get special rules for cases like his.

Plaintiff dragged out Summers v. Tice and the Pennsylvania equivalent, Snoparsky v. Baer, 266 A.2d 707 (Pa. 1970), to suggest that he should get a lessened causation burden under an alternative joint liability theory.  Id. at *6-7.  Summers is the famous hunting accident case and Snoparsky involved a child’s injury from getting hit by a rock thrown by one of a group of rock-throwing children.  “[T]his doctrine exists to redress harms caused by one defendant from within a comprehensive, but otherwise limited, pool of potential harm-doers, only when determining fault is otherwise impossible.”  Id. at *7.  Plaintiff’s attempt to impose simultaneous liability on eleven manufacturers for making 179 products that were not alleged to be the only contributors to his alleged injuries was not remotely like the limited cases that had accepted this unusual theory.  The old DES case in the Philadelphia Court of Common Pleas that permitted alternative joint liability involved identical products made by multiple manufacturers that controlled substantially all the market but the plaintiff could not determine whose DES her mother took long ago.  Id. at *7-8 (discussing Erlich v. Abbott Labs., 5 Phila. 249 (Phila. Ct. Com. Pls. 1981)).  By contrast, the Martinez plaintiff’s suit sought to impose liability against eleven defendants that made many different products he claimed to have consumed.  The Eastern District of Pennsylvania had previously rejected the theory in another case seeking to impose liability for a physical injury on eleven defendants that made different products to which plaintiff claimed exposure over time.  Id. at *7 (discussing Klein v. Council of Chem. Assocs., 587 F. Supp. 213 (E.D. Pa. 1984)).  “[G]iven Pennsylvania’s hesitance to expand the alternative liability doctrine beyond those involving identical products,” the court could not take the “significant logical leap” to apply it to this case.  Id. at *8.  Had Martinez acknowledged the need for Erie restraint, the required leap would have been even harder.

Martinez also entertained the market share liability theory that had originated in the notorious California Sindell DES case.  It noted that the Southern District of New York had predicted, despite an acknowledgement of Erie restraint, that the Pennsylvania Supreme Court would likely adopt market share liability in a groundwater contamination case involving fungible products made by multiple manufacturers.  Id. at *8 (discussing In re Methyl Tertiary Butyl Ether (MTBE) Prods. Liab. Litig., 379 F. Supp. 2d 348 (S.D.N.Y. 2005)). The allegations in Martinez, however, were not close to that fact pattern, including because its defendants sold different products with different alleged problems.  If Martinez had checked the Blog, it would have seen a number of cases rejecting market share liability under Pennsylvania law in situations that were much closer to basic facts in Martinez, but a deeper dive was not needed to reject market share liability.  Nor did the court suffer the failing of many courts to give plaintiff a third bite at the proverbial apple:

The FAC fails to establish but-for causation because it lacks sufficient facts showing each Defendant or product individually caused or contributed to his harm.  Removing one Defendant or one product illustrates the deficiencies—the outcome would not change.  Alternative liability and market share liability cannot save Martinez’s claims because Defendants’ products and the dangerous chemicals contained therein are not the same.  For these reasons, leave to amend must be denied.

We note that Martinez did not go further and address whether plaintiff’s liability allegations were sufficient.  We have our doubts.  Plaintiff had alleged that all of the products were designed and marketed to “promot[e] subconscious overconsumption.”  In other words, the plaintiff lawyers were following the social media playbook that demonized the edible version of infinite scrolling and minimized personal responsibility.  The reptilian appeal of the typical plaintiff tactics may or may not translate to sweeping attacks on food and beverages, whether lumped together under the label of ultra-processed, genetically-modified, shelf-stable, or something else.  After all, ascribing negative mental health impacts to the plaintiff’s use of a specific application, website, or chat bot is a far cry from ascribing the plaintiff’s development of diseases that occur in the general population collectively to his consumption of a number of different foods and beverages over the course of many years.  As oversimplified, if not unscientific, as many discussions of public health have become, it would be particularly simplistic to make the precise source of the roughly 12 million calories that the plaintiff in Martinez would have consumed from when he started consuming the defendants’ 179 different products until he was diagnosed with type 2 diabetes and steatohepatitis the sole focus.  Designing or marketing a food so that people continue to buy and consume it does not sound tortious.  It sounds pretty normal.  By contrast, how a company’s particular food products fit into larger public health issues like increasing rates diabetes diagnoses among teens is very complex.

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Lately, weirdly, sadly, some people have suggested that the Enlightenment was a mistake. They contend that an overemphasis on rationality robbed humanity of feeling, faith, etc. What drivel. Every day of the week, we’ll take Voltaire over any pretend-King, data over dogma, and science over stupidity. 

Thus, we are pleased with Miller v. McDonald, 2026 WL 1871521 (2d Cir. June 30, 2026), another appellate win for mandatory school vaccination requirements.  

The opinion begins with a recitation of New York’s history of regulating immunization in schools. In 1860, New York empowered school officials to deny admission of unvaccinated students. There were exemptions for students who could not be vaccinated for medical reasons or those whose parents held religious objections. Much more recently, in 2018-19, New York became the epicenter of a measles outbreak. Following that outbreak, the legislature repealed the religious belief exemption but not the medical exemption. Various Amish community schools and their officials brought this lawsuit under 42 USC section 1983, alleging that the immunization law infringed their free exercise rights under the First and Fourteenth Amendments. The plaintiffs also argued that the law impaired the right of parents to control the religious upbringing of their kids. 

The plaintiffs relied on Wisconsin v. Yoder, 406 U.S. 205 (1972), a case studied by pretty much everyone who attended law school over the last 50 years. In Yoder, the Supreme Court held that the First Amendment free exercise right of Amish parents outweighed the state’s interest in compelling school attendance beyond eighth grade. That precedent might not be precisely on point, but it is pretty helpful for the plaintiffs. But it was not helpful enough.  

The district court in Miller granted the state’s motion to dismiss and the Second Circuit affirmed. But then the United States Supreme Court granted certiorari, vacated the judgment, and sent the case back for reconsideration in light of Mahmoud v. Taylor, 606 U.S. 522 (2025). In Mahmoud, the Supreme Court overturned a school board’s refusal to allow parents to opt their young children out of classroom instruction using storybooks that conveyed messages contrary to the parents’ religious briefs.  

Thus, the Miller plaintiffs got a do-over. But after going through an analysis of the free exercise claims and the interplay of Mahmoud with Yoder, the Second Circuit decided it had been right all along and, again, affirmed dismissal of the case. Again, the Second Circuit held that New York did not act unconstitutionally when it repealed its religious exception to mandatory vaccination following a measles outbreak.  

The Second Circuit began its analysis with the observation that generally applicable vaccination requirements do not unconstitutionally burden the free exercise of religion. For the umpteenth time, we are treated to a citation to the Jacobson (1905) case in which the Supreme Court upheld a Massachusetts law requiring vaccination against smallpox. A neutral vaccination mandate need pass only rational basis review.  By contrast, a vaccination law animated by hostility to a particular religious sect would face fatal-in-fact strict scrutiny. As in Jacobson, the New York vaccination mandate was religiously neutral, and addressed a legitimate governmental interest in preventing communicable disease. It was an easy rational basis case. “Government is generally free to place incidental burdens on religious exercise so long as it does so pursuant to a neutral policy that is generally applicable.”  Repealing a religious exemption does not transmute an otherwise neutral law into one that targets religious belief.  The legislative history, read as a whole, does not show religious bias. (There might have been some isolated bits supporting the plaintiffs’ suspicion of bias, but they were isolated and unrepresentative, and serve as reminders of why Justice Scalia was deeply skeptical of legislative history.) Providing medical exemptions does not require providing religious ones.  The two are not comparable.  The medical exemption is the same as other vaccination exemptions that are constitutionally permissible.  

Further, mandatory vaccination does not unconstitutionally burden parental rights.  It is a general health requirement that does not seek to change any child’s religious belief. The burden of mandatory vacination “is not remotely of the same character as those imposed in Yoder and Mahmoud. The law is a public health measure, not an instrument of ideological indoctrination. It does not expose children to values or beliefs that might be hostile to their parents’ religious beliefs.”

Score one for public health. And while we’re at it, score one for leading figures of the Enlightenment, such as Montesquieu, Adam Smith, and, yes, John Adams and Thomas Jefferson. 

Post-script: On June 29, the Supreme Court denied certiorari in another vaccine-related appeal, Doe v. Hochul, from another Second Circuit/NY decision, that made similar religiously based attacks on mandatory vaccination, in that case, employment-related.  Doe had been hanging around all term, with more than the average amount of activity,  https://www.scotusblog.com/cases/does-1-2-v-hochul/.

The day after the denial, the Second Circuit handed down Miller.  Maybe a coincidence, maybe not.

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We have written before about the Taxotere eye injury MDL — and we wish we could say things were getting better. They are not.

Last December, we noted the fundamental absurdity at the heart of this litigation. Cancer patients — many of them breast cancer patients — were given Taxotere, a chemotherapy drug. The label warned that excessive tearing “may be attributable to lacrimal duct obstruction.” Plaintiffs’ lawyers, never ones to let adequate warnings stand in the way of a good MDL, decided that was not good enough. They wanted the label to say the tearing may be caused by “stenosis of the nasolacrimal drainage system.” And so we have, as we put it before, thousands of lawsuits, nearly a decade of litigation, and only the lawyers reaping anything other than minimal benefit.

Now the same MDL court has denied the defendant’s motion for summary judgment on warning adequacy. In re Taxotere (Docetaxel) Eye Injury Products Liability Litigation, 2026 WL 1839097 (E.D. La. June 25, 2026). The court managed to find genuine disputes of material fact lurking in what is, at bottom, a series of complaints that could be described as the medical terminology equivalent of arguing about whether a “hot dog” is a “sandwich.” The court did not even bother to apply the law of any particular state, applying instead a kind of generalized, multi-jurisdictional soup of failure-to-warn principles. The result is a roadmap for how to nitpick a warning to death.

Let us count the ways plaintiffs were permitted to pick apart an otherwise adequate warning.

Number 1. The label warned of “lacrimal duct obstruction.” Plaintiffs argued it should have said “nasolacrimal drainage system.” The defendant’s regulatory expert opined there was no material distinction between the two — that “nasolacrimal” and “lacrimal” do not “inherently change the characterization of the condition or impart additional or more useful information for the prescriber.” Id. at *5. On the other side, one of plaintiffs’ experts opined that “lacrimal duct obstruction is not terminology he uses in his practice.” Id. He didn’t say he didn’t understand the term, just that he personally does not use it. The court found a jury question. We find an eye roll.

Number 2. The defendant pointed to Stedman’s Medical Dictionary, which defines “obstruction” as a “blockage or clogging, e.g., by occlusion or stenosis.” Id. at *4. Stenosis, in other words, is one of the things that causes obstruction. Obstruction is the thing the label warned about. So the label warned about the thing caused by the thing plaintiffs say should have been mentioned. Plaintiffs countered with a different edition of the same dictionary that defines stenosis as a “narrowing” and cautions not to confuse it with “occlusion.” Id. The court found a jury question. We find it hard to keep a straight face.

Number 3. The label did not specifically say the condition could become permanent. Plaintiffs say it should have. To compound matters, the label noted that certain visual disturbances were “reversible upon discontinuation of infusion.” Defendant argued, correctly, that this referred to the immediately preceding sentence about transient visual disturbances during infusion — not to lacrimal duct obstruction, which appeared several sentences earlier. The court disagreed. Viewing everything in the light most favorable to plaintiffs, the court found a jury could conclude the label misleadingly implied the tearing risk was also reversible. Id. at *6.

Number 4. Plaintiffs’ expert opined the label should have warned physicians to promptly refer patients to an ophthalmologist upon signs of excessive tearing and mentioned the potential need for surgical intervention. This, as we have noted before, is the pharmaceutical equivalent of requiring a car manufacturer to tell drivers how to parallel park. Labels are not required to instruct physicians on how to practice medicine. The court acknowledged that manufacturers generally need not instruct physicians how to manage disclosed side effects, but found this wasn’t necessarily a “management instruction” and again found a jury question. Id. at *6.

And number 5. On top of all of that, plaintiffs’ expert opined the warning should have appeared in the “Warnings and Precautions” section rather than in the “Adverse Reactions” section. The court let that theory survive too. Id. at *7. This, again, is a theory we have seen before and continue to find unpersuasive — especially for a risk that is, let’s remember, associated with a chemotherapy drug being given to cancer patients.

Before getting to the merits of the warning claims, the court noted something worth flagging: it wasn’t going to apply the law of any particular state. Plaintiffs didn’t argue for an individualized choice-of-law analysis, and the court was apparently content to proceed under a generalized “common principles” approach. Id. at *4.

In an MDL involving thousands of plaintiffs from dozens of states, that is a curious thing. The whole point of Erie is that federal courts sitting in diversity apply state law — not a blended smoothie of principles that happen to be shared by most states. Different states have different standards for warning adequacy. Some apply the learned intermediary doctrine more rigorously; some have statutory presumptions; some are more forgiving of general warnings; some require specific causal language. A ruling that deliberately declines to engage with any of that is a ruling built on a foundation that can shift at any moment — which is bad for everyone, including plaintiffs, though they may not see it that way right now.

Even setting aside all of the above, we are compelled to return to the point we made in December, because it has not gotten any less true: these plaintiffs still have to prove warnings causation.

Under the learned intermediary doctrine — which the court acknowledges applies here — adequacy is measured by whether the prescribing physician would have reasonably understood the risk. Id. at *3. And even if the jury somehow finds the warning inadequate, each plaintiff must then show that a different warning would have changed her oncologist’s prescribing decision.

So. How many oncologists are going to take the stand and testify: “Yes, I would not have prescribed potentially life-saving chemotherapy to this very sick cancer patient had I only been formally instructed that the excessive tearing due to duct obstruction was because of stenosis of the nasolacrimal drainage system, and that I should refer to an ophthalmologist promptly”?

In a non-insane world, this should be something very difficult to prove. Oncologists treat cancer. They weigh the risks of chemotherapy — real risks, like neutropenia, neuropathy, and secondary malignancies — against the risk of dying from cancer. The suggestion that the difference between “lacrimal duct obstruction” and “stenosis of the nasolacrimal drainage system” would have led any oncologist to withhold chemotherapy from a cancer patient strains credulity past the breaking point.

But here we are. Thousands of cases. Nearly a decade. And counting.

If beauty is in the eye of the beholder, this MDL court seems to see beauty in every alleged gap in a warning label — no matter how fine the distinction, no matter how unlikely it would have changed anything, and no matter what state’s law is supposed to govern.

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We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation.  The reason is simple − our clients (and target audience) can be found on either side of the “v.”  So, it’s best that we leave the offering of opinions on patent/IP issues to others.

That certainly wasn’t a problem with the recent Hikma “skinny label” patent decision, Hikma Pharmaceuticals USA, Inc. v. Amarin Pharma, Inc., 146 S. Ct. 1391 (U.S. 2026).  Hikma touched off a torrent of patent-related commentary – see, e.g., here, here, here, here, here, here, here, here, and here.  We wouldn’t have been able to match that, since we’re product liability, not patent, lawyers.

But we do think that Hikma has implications for product liability litigation as well.  For one thing, it has off-label use issues throughout, even though that phrase is not directly mentioned (the decision uses “off-patent” as the equivalent).  Hikma involved the drug Vascepa, manufactured by the plaintiff/respondent Amarin Pharma.  That’s a tip off right there.  The same drug, and the same manufacturer, produced the landmark off-label use decision, Amarin Pharma, Inc. v. FDA, 119 F. Supp.3d 196 (S.D.N.Y. 2015), that we named our sixth best case of 2015.  Amarin beat the FDA on First Amendment grounds after the agency threatened to take enforcement action against the company for truthful off-label speech:

Plaintiff  . . . Amarin[] manufactures . . . Vascepa.  The FDA has approved Vascepa for one use, but doctors have widely, and lawfully, prescribed it for another.  Amarin wishes to make truthful statements to doctors relating to Vascepa’s off-label use. . . .  [that] the FDA largely but not wholly concedes . . . are truthful and non-misleading.  However, the FDA, recognizing that Amarin’s purpose . . . would be to promote an unapproved use of Vascepa, has threatened to bring misbranding charges against Amarin (and, presumably, its employees) if it does so.

119 F. Supp.3d at 198.  The initial, limited, FDA approval for Vascepa – that also made off-label use possible − occurred in 2012.  Id. at 209.

Fast forward ten years.  As Hikma discussed, “[i]n 2019, . . . the FDA approved Vascepa for a second, much more common use.”  146 S. Ct. at 1398.  The use approved in 2019 was the same use that was off-label in 2015 and was the subject of Amarin’s win over the FDA.  The more limited Vascepa use originally approved in 2012 was the same one allowed by the “skinny label” for the generic competitor in Hikma, since Amarin’s original patent for that use − but not for the more lucrative use ultimately approved in 2019 – had expired.  Id. (“Hikma [the generic defendant] now sought approval of a skinny label that included only the [more limited use that was] no longer protected by [the relevant] patent”).

Thus, the same off-label use issue existed between the parties in Hikma that had been litigated between the FDA and Amarin in 2015 – only the interested parties were different.  The FDA had been defanged and took no action against any off-label generic promotion of the same, broader use.  Instead, Amarin, the branded manufacturer, sued the generic (Hikma) on a patent-based theory that paralleled the FDA’s threatened enforcement action from 2015:

Soon after [the generic defendant] began marketing its generic drug, Amarin filed suit . . ., alleging that [defendant] had actively induced others to infringe Amarin’s patent for the [more lucrative] method of use.  Amarin alleged that the totality of [defendant’s] statements across several documents encouraged infringing uses.

Id.  Since, as Buckman has taught us, private parties cannot enforce the FDCA, the patent claim in Hikma was phrased differently – as “induced infringement” – but functionally it involves “encouragement” via speech, which is closely parallel to the FDA’s concept of “off-label promotion.”  Indeed, given the “skinny label,” the use that the generic defendant allegedly sought to induce was necessarily also off-label, since the omission of “the carved-out use” is what made the generic defendant’s label “skinny” in the first place.  Id. at 1401.

Which leads us to what the Supreme Court found lacking about the induced infringement that was pleaded in Himka.  It is not enough under Rules 8 and 12 simply to “allege a plausible chain of events through which statements made by [the defendant] could lead a healthcare provider to prescribe or dispense [defendant’s] drug” for an off-label/off-patent use.  146 S. Ct. at 1400 (quotation marks omitted).  Instead:

  • A defendant must take “affirmative steps to encourage infringement.”  Id. at 1401.
  • Statements that “comply[] with the law or with standard industry practice” are insufficient to create inducement liability.  “[A]dherence to the law and industry standards” are not “building blocks for illegal conduct.”  Id.
  • Plaintiffs “may not rely on mere omissions, inactions, or nonfeasance” to allege active inducement.”  Id. at 1402 (citation and quotation marks omitted).
  • “[W]e look for affirmative statements or actions . . . to avoid trenching on regular commerce based on such a contingent chain of events.  Otherwise, ordinary merchants could become liable for any misuse of their goods and services [by their customers], no matter how attenuated their relationship with the wrongdoer.”  Id.
  • “[V]ague statements combined with speculation about how medical providers may act in response to those statements” “come[] up short” as pleadings.  Id. (citation and quotation marks omitted).
  • Since the relevant statute “requires active not passive, inducement . . ., the question is not merely whether the statements could be plausibly understood to induce infringement, but whether they plausibly constitute affirmative steps to bring about the desired result of infringement.”  Id. (citation and quotation marks omitted).
  • Statements such as “a warning and a disclaimer” cannot be “active inducement of infringement” because they “are implausibly roundabout ways to induce medical providers to infringe” by engaging in off-label use.  Id.

The FDA’s intended use regulations, 21 C.F.R. §§201.128 (drugs), 801.4 (medical devices), as amended in 2021 (see our post here) contain similar language.  They rely on “objective” intent as “shown by labeling claims, advertising matter, or oral or written statements.”  Id.  Specifically, “intent” cannot exist “based solely on [a regulated entity’s] knowledge that such drug [or device] was being prescribed or used by health care providers for such use.”  Id.  Thus, we think that the pleading requirements for induced infringement” through encouragement of off-label use that the Court imposed in Hikma should be equally applicable to allegations that off-label speech affects a product’s “intended use” under these regulations.  It’s the same speech, subject to an equivalent affirmative intent legal element, concerning identical conduct – alleged encouragement of physician off-label use.

In addition, we think that the requirement of “active” inducement enforced in Hikma means that the latest ridiculously pro-plaintiff law review article that we’ve read, D. Simon, “Off-Label Inducement,” 111 Iowa L. Rev. 1181 (2026), is dead on arrival.  The entire premise of that article is application of “intellectual property” inducement concepts to tort law in order to create “a new theory of liability” − off-label inducement − that would hold a manufacturer liable if its speech “induces a provider to negligently prescribe, administer, or use its drug or device off-label.”  Id. (at abstract).  The article would allow liability on “evidence of a general awareness of a role in an improper activity.”  Id. at 1196.  Its “negligence” standard would not require “that the manufacturer actually knew that the promoted use was malpractice” – only that it was “foreseeable . . . regardless of the manufacturer’s intent.”  Id. at 1198.  Specifically relying on cases (including the decision reversed in Hikma), the article proposes:

[P]romotional activities can be a legal cause of the underlying tort, even if the promotion is not explicit about what it wants the infringer to do. . . .  [W]hat is problematic is the underlying behavior the speech encourages, rather than the speech itself[ such as] truthful commercial speech [that] accurately described the generic as “therapeutically equivalent to the brand product.”  But . . . in so doing, it implied that physicians should prescribe it for all uses, including the patented ones.  Even though it was truthful, the advertising could be prohibited because it encouraged tortious behavior.

Id. at 1208-09 (footnotes omitted).  But that is exactly what Hikma held was insufficient – right down to “therapeutically equivalent” claim.  See Hikma, 146 S. Ct. at 1401 (“it is normal industry practice to truthfully describe a generic drug as ‘equivalent’ to the brand-name comparator.”) (citation omitted).

Initially, we thought the “Off-Label Inducement” article was so far off the wall we weren’t going to bother with it – until Hikma obliterated the article’s core proposition less than three months after the article was published.  That’s a mercifully quick interment of a bizarre and unprecedented theory of liability.

*          *          *          *

However, there is a second, and broader way that we think Hikma is important to our sandbox.  It’s a Supreme Court application of TwIqbal’s “well-established federal pleading standard” specifically in the pharmaceutical context.  146 S. Ct. at 1399.  

[TwIqbal’s] plausibility standard asks for more than a sheer possibility that a defendant has acted unlawfully.  If the complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.  Instead, to nudge a claim across the line from conceivable to plausible, a plaintiff must plead facts that, if true, allow the court to draw the reasonable inference that the defendant is liable for the misconduct alleged, and to rule out obvious alternative explanations for the defendant’s conduct.

This case requires us to apply these familiar pleading standards to the third element of an induced-infringement claim: that the inducer took active steps to encourage direct infringement.

Id. (numerous TwIqbal citations and accompanying quotation marks omitted).  So, maybe “TwIqbal” should become “Twiqbalma.”

Nah.

But this standard does apply to all pleadings.  Hikma should mean, for example, that for any liability theory premised on “affirmative, as opposed to passive, steps,” Rules 8 and 12 cannot be satisfied by allegations of “mere omissions, inactions, or nonfeasance.”  146 S. Ct. 1400, 1402.  Hikma should apply to the pleading of any claim (such as providing information or aiding and abetting) that seeks to impose liability on a defendant for conduct that purportedly encourages others to engage in supposedly tortious conduct.  For one thing, the pleading standards listed above should apply to motions to dismiss allegations involving sales representatives, which are a common preemption dodge in prescription medical product liability litigation.

Thus, for all these reasons, we think that Hikma should have significant impact on litigation not involving patents or intellectual property – and its toughened pleading standards are particularly applicable to prescription medical product liability litigation.

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